中华皮肤科杂志
中華皮膚科雜誌
중화피부과잡지
Chinese Journal of Dermatology
2011年
4期
241-243
,共3页
宗文凯%崔盘根%陈志强%王宝玺%李红春%顾军%陈洁%温海%顾菊林%于浩%娄冬华
宗文凱%崔盤根%陳誌彊%王寶璽%李紅春%顧軍%陳潔%溫海%顧菊林%于浩%婁鼕華
종문개%최반근%진지강%왕보새%리홍춘%고군%진길%온해%고국림%우호%루동화
神经性皮炎%复方倍他米松注射液%随机对照试验
神經性皮炎%複方倍他米鬆註射液%隨機對照試驗
신경성피염%복방배타미송주사액%수궤대조시험
Neurodermatitis%Compound betamethasone injection%Randomized controlled trials
目的 评价国产复方倍他米松注射液局部单次注射治疗神经性皮炎的安全性和疗效.方法 采用多中心、随机盲法、阳性药物平行对照的临床研究.受试者分别接受国产和进口复方倍他米松注射液治疗.在治疗前(D0)、治疗中(D14)及治疗后(D28)分别对各观察指标进行评估记录.结果 共入组病例144例,完成试验139例,其中对照组68例,试验组71例.疗后4周FAS分析显示,对照组有效率为86.11%,试验组为86.11%(χ2=0.00,P>0.05).痊愈率对照组为59.72%,试验组为54.17%(χ2=0.45,P>0.05).治疗结束时无严重不良事件出现,仅对照组有1例发生轻度皮肤萎缩,经随访自行好转,两组不良反应发生率差异无统计学意义(P>0.05).结论 国产复方倍他米松注射液治疗神经性皮炎安全有效.
目的 評價國產複方倍他米鬆註射液跼部單次註射治療神經性皮炎的安全性和療效.方法 採用多中心、隨機盲法、暘性藥物平行對照的臨床研究.受試者分彆接受國產和進口複方倍他米鬆註射液治療.在治療前(D0)、治療中(D14)及治療後(D28)分彆對各觀察指標進行評估記錄.結果 共入組病例144例,完成試驗139例,其中對照組68例,試驗組71例.療後4週FAS分析顯示,對照組有效率為86.11%,試驗組為86.11%(χ2=0.00,P>0.05).痊愈率對照組為59.72%,試驗組為54.17%(χ2=0.45,P>0.05).治療結束時無嚴重不良事件齣現,僅對照組有1例髮生輕度皮膚萎縮,經隨訪自行好轉,兩組不良反應髮生率差異無統計學意義(P>0.05).結論 國產複方倍他米鬆註射液治療神經性皮炎安全有效.
목적 평개국산복방배타미송주사액국부단차주사치료신경성피염적안전성화료효.방법 채용다중심、수궤맹법、양성약물평행대조적림상연구.수시자분별접수국산화진구복방배타미송주사액치료.재치료전(D0)、치료중(D14)급치료후(D28)분별대각관찰지표진행평고기록.결과 공입조병례144례,완성시험139례,기중대조조68례,시험조71례.료후4주FAS분석현시,대조조유효솔위86.11%,시험조위86.11%(χ2=0.00,P>0.05).전유솔대조조위59.72%,시험조위54.17%(χ2=0.45,P>0.05).치료결속시무엄중불량사건출현,부대조조유1례발생경도피부위축,경수방자행호전,량조불량반응발생솔차이무통계학의의(P>0.05).결론 국산복방배타미송주사액치료신경성피염안전유효.
Objective To evaluate the safety and efficacy of single and local use of a China-made compound betamethasone injection in the treatment of lichen simplex chronicus. Methods A multi-center,randomized, parallel controlled study was conducted. Patients with lichen simplex chronicus were divided into test and control groups to receive a single dose of intralesional compound betamethasone injection made in China or Schering-Plough Labo N.V. Belgium. Patients were visited for the evaluation of efficacy and safety of the China-made injection at the beginning of the treatment (DO), on week 2 (D14) and 4 (D28) after the initiation of treatment. Results A total of 144 patients were enrolled, among which, 68 in the control group and 71 in the test group completed the trial. FAS analysis on week 4 revealed that the response rate and healing rate were 86.11% and 59.72% in the control group, respectively, 86.11% and 54.17% in the test group, respectively (χ2=0.00,0.45,respectively,both P>0.05).There was no severe adverse event in either group after the treatment, and only mild atrophoderma occurred in one patient in the control group, which was improved spontaneously within several weeks of follow-up. There was no statistically significant difference in the occurrence of side reactions between the two groups (P> 0.05). Conclusion The China-made compound betamethasone injection is effective and safe for the treatment of lichen simplex chronicus.
